Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention (GAMEPLAN)

Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention (GAMEPLAN)

This study aims to determine the independent and combined effects of prebiotic fiber supplementation and exercise on the gut microbiome and human health.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Fructooligosaccharides (FOS); Behavioral: Exercise; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mikaela Webb, BS, RD; Phone Number: (217) 300-9577; Email: mwebb24@illinois.edu

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • University of Illinois at Urbana-Champaign
      • Contact: Mikaela Webb, BS, RD
      • Principal Investigator: Jacob M Allen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI 18.5-45 kg/m2
• Without physician diagnosed gastrointestinal or metabolic diseases
• Sedentary (< 30 minutes of moderate or high intensity exercise per week OR < 20 aggregate Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ; GodinLeisure) score)
• Fully vaccinated against COVID-19

Exclusion Criteria:

• Fasting blood glucose >126 mg/dL
• Blood pressure >160/100 mm Hg
• Physician diagnosed metabolic or gastrointestinal diseases or constipation
• Heart conditions that may pose risk during exercise
• Taking oral hypoglycemic agents or insulin
• Pregnant, breastfeeding or postmenopausal
• Smoke or consume > 2 alcoholic beverages/day, abuse drugs
• Have had > 5% weight change in the past month or > 10% change in the past year
• Have had any form of bariatric surgery or gallbladder removal
• Have taken antibiotics during the previous 3 months
• Unable to consume the experimental fiber

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise + Prebiotic; The Exercise + Prebiotic intervention group will consume 10 g/d of fructo-oligosaccharides (FOS). Additionally, they will perform 6 wk. of supervised progressive multi-component exercise training consisting of moderate to vigorous aerobic and strength-based exercises (3x/wk).	Dietary supplement: Fructooligosaccharides (FOS); FOS (NUTRAFLORA® P-95, Ingredion) supplements (10g/day) will be consumed daily mixed with water.; Behavioral: Exercise; During the intervention period, all participants will perform 6 weeks of supervised progressive multi-component exercise training consisting of moderate to vigorous aerobic and strength-based exercises (3x/wk.).
Placebo Comparator: Exercise + Placebo; The Exercise + Placebo group will consume 10 g/d of a placebo (maltodextrin) powder every day. Additionally, they will perform 6 wk. of supervised progressive multi-component exercise training consisting of moderate to vigorous aerobic and strength-based exercises (3x/wk).	Behavioral: Exercise; During the intervention period, all participants will perform 6 weeks of supervised progressive multi-component exercise training consisting of moderate to vigorous aerobic and strength-based exercises (3x/wk.).; Dietary supplement: Placebo; Maltodextrin (Globe 18DE Maltodextrin, Ingredion) supplements (10g/day) will be consumed daily mixed with water.; Other Names: Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in gastrointestinal microbiota composition	Determine the impact of daily consumption of prebiotic combined with regular exercise on the gastrointestinal microbiota compared to control by sequencing the V4 region of the 16S rRNA gene in fecal samples.	Baseline & 6-week mark
Changes in gastrointestinal microbial-derived metabolite concentrations	Determine the impact of daily consumption of prebiotic combined with regular exercise on the concentration of short-chain fatty acids compared to control.	Baseline & 6-week mark

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in fasting glucose	Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting glucose compared to control.	Baseline & 6-week mark
Changes in fasting insulin	Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting insulin compared to control.	Baseline & 6-week mark
Changes in body composition	Determine the impact of daily consumption of prebiotic combined with regular exercise on body composition compared to control. This includes percentage of fat mass and lean mass.	Baseline & 6-week mark
Changes in body fat distribution	Determine the impact of daily consumption of prebiotic combined with regular exercise on body fat distribution compared to control. This includes the weight of visceral fat and liver fat in kilograms.	Baseline & 6-week mark
Changes in cognition	Determine the impact of daily consumption of prebiotic combined with regular exercise on relational memory, hippocampal function, interference control, and selective attention compared to control. Outcomes will be assessed with computer tasks and participants will be equipped with an electrode cap.	Baseline & 6-week mark

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in lipid profiles	Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting lipid profiles including cholesterol and triglycerides compared to control.	Baseline & 6-week mark

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): September 20, 2023
• Study Completion (Anticipated): September 20, 2023

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Prebiotic; Fiber; Body composition; Cognition; Glucose homeostasis; Short-chain fatty acids; Gastrointestinal microbiota; Fructooligosaccharides
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 21730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No